Portex 100/597/080CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 15019315107146), received between Dec 19, 2018 and Oct 30, 2025 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT CUFF WAS LEAKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430498 ↗
• MalfunctionOct 22, 2024Material Too Soft/Flexible; Material Split, Cut or Torn; Material Too Soft/Flexible; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRE-DILATOR TIP WAS SPLITTING WHEN BEING FED DOWN THE GUIDEWIRE FOR TRACHEOTOMY PROCEDURE. THE DILATOR'S PLASTIC WAS VERY SOFT AND MALLEABLE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507800 ↗
• MalfunctionMay 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CANNULA WAS LEAKING AT THE ENTRANCE FROM THE BLUE CUFF LUMEN INTO THE CANNULA. TRACH CHANGE TOOK PLACE REGARDING DEFECTIVE CUFF. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846770 ↗
• MalfunctionFeb 24, 2023Inadequacy of Device Shape and/or Size; Defective Component; Inadequacy of Device Shape and/or Size; Defective Component

  IT WAS REPORTED THAT THE PURPLE INTRODUCER FOR THE INNER CANNULA IS TOO BIG TO PUSH DOWN THE TUBE ON THIS OCCASION. THIS HAPPENED WITH TWO FROM THE SAME LOT. CUSTOMER HAD TO OPEN A THIRD TUBE WHICH WAS A SIZE 7 FOR THE SIZE 8 TUBE TO BE ABLE TO BE INSERTED PROPERLY AND RESOLVE THE ISSUE. REPORTER STATED THE ISSUE WAS FOUND WHILE IN USE WITH A PATIENT AND "LUCKILY, THIS WAS A CONTROL TRACHEOSTOMY IT COULD HAVE BEEN POTENTIALLY LIFE THREATENING IN AN EMERGENCY." THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16438757 ↗
• MalfunctionFeb 24, 2023Inadequacy of Device Shape and/or Size; Defective Component; Inadequacy of Device Shape and/or Size; Defective Component

  IT WAS REPORTED THAT THE PURPLE INTRODUCER FOR THE INNER CANNULA IS TOO BIG TO PUSH DOWN THE TUBE ON THIS OCCASION. THIS HAPPENED WITH TWO FROM THE SAME LOT. CUSTOMER HAD TO OPEN A THIRD TUBE WHICH WAS A SIZE 7 FOR THE SIZE 8 TUBE TO BE ABLE TO BE INSERTED PROPERLY AND RESOLVE THE ISSUE. REPORTER STATED THE ISSUE WAS FOUND WHILE IN USE WITH A PATIENT AND "LUCKILY, THIS WAS A CONTROL TRACHEOSTOMY IT COULD HAVE BEEN POTENTIALLY LIFE THREATENING IN AN EMERGENCY." THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16438319 ↗
• InjuryJan 6, 2023Break; Break

  IT WAS REPORTED THAT FOLLOWING AN EPISODE OF RESPIRATORY FAILURE EXPERIENCED BY A 76-YEAR-OLD PATIENT, THE TRACHEOSTOMY TUBE TIGHTENING RING WAS FOUND TO BE BROKEN 2-3 DAYS AFTER THE INITIAL INSERTION. THIS EVENT EXPOSED THE PATIENT TO THE RISK OF LOSS OF AIRWAY CONTROL WITH A RISK OF DEATH. THIS INCIDENT RESULTED IN THE EARLY CHANGE OF THE TUBE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16111798 ↗
• MalfunctionOct 25, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUFF MAY HAVE AN AIR LEAK. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668399 ↗
• MalfunctionSep 27, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE CLAMP TO BLOCK THE TUBE WAS DEFECTIVE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494697 ↗
• MalfunctionAug 4, 2021Complete Blockage; Complete Blockage

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC REQUIRED INTERVENTION TO PRECLUDE SERIOUS IMPAIRMENT. ON (B)(6) 2021 0800HRS NOTICED BLUE LEVER (LOCKING MECHANISM) ON TRACHESOTOMY WAS PARTIALLY LIFTED AND UNLOCKED. TRACHEOSTOMY REMAINED IN GOOD POSITION, NIL ISSUES WITH VENTILATION. VITAL SIGNS NAD.( NO ACTUAL DISTRESS) RE-LOCKED. NO FURTHER ISSUE REPORTED UNTIL. DECANNULATED (B)(6) 2021.

  Patient problems: Hypoxia

  MAUDE report 12276479 ↗
• MalfunctionJul 15, 2021Difficult to Open or Close; Difficult to Open or Close

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC CAUSED INCIDENT .REPORTED VI EMAIL ;STAFF REPORT THAT THE PATIENT PARTIALLY COUGHED HIS TRACHE OUT, IT WAS DISLODGED BY 1-2CM. THE MEDICAL STAFF PERFORMED A BRONCHOSCOPY TO ENSURE THAT THE TUBE REMAINED IN HIS AIRWAY AND THEN IT WAS ADVANCED BACK IN BY 2CM. ONCE THE TRACHE WAS IN POSITION THE LOCKING MECHANISM, WHICH WAS PREVIOUSLY LOCKED TIGHTLY INTO POSITION, WAS LOOSE AND UNABLE TO BE LOCKED. THIS RESULTED IN THE TRACHEOSTOMY HAVING TO BE REMOVED. ADDITIONAL INFORMATION LATER SATED STAFF DO NOT RECALL MANIPULATING THE LOCK AND THE PATIENT DID NOT HAVE THE CAPABILITY TO TOUCH THE LOCK. WE ARE VERY UNCLEAR HOW THE INCIDENT OCCURRED SO AS A PART OF THE INVESTIGATION INTO THIS EVENT AND NEED TO ASK THE COMPANY OF ANY OTHER SIMILAR INCIDENTS WHERE THE LOCKING MECHANISM HAS BECOME FAULTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173313 ↗
• MalfunctionJul 20, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED INDICATING THAT DURING PLACEMENT OF A SMITHS MEDICAL PORTEX UNIPERC PERCUTANOUS KIT AND TRACHEOSTOMY TUBE, IT WAS REPORTED THE OBTURATOR WAS UNABLE TO BE INSERTED INTO THE TRACH TUBE. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10296434 ↗
• InjuryJun 19, 2019Leak/Splash; Decrease in Pressure; Leak/Splash; Decrease in Pressure

  IT WAS REPORTED THAT THERE WAS A LACK OF PRESSURE IN THE CUFF AND DIFFICULTY IN ACHIEVING THE MECHANICAL VENTILATION. AFTER REMOVAL OF THE CANNULA, THE LEAK TEST WAS CARRIED OUT AND A LEAK AT THE LEVEL OF THE CONNECTION BETWEEN THE CANNULA AND INFLATION DEVICE WAS DETECTED. THE PATIENT WAS OBESE AND WAS AFFECTED BY ACUTE RESPIRATORY FAILURE AND REQUIRED PROLONGED VENTILATION AS A RESULT. THE TRACHEOSTOMY AND THE CANNULA HAD BEEN IN USE FOR 80 MINUTES BEFORE THE DEFECT WAS OBSERVED. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Respiratory Failure

  MAUDE report 8714373 ↗
• MalfunctionFeb 20, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A ""DIE CUFF" WITHIN A SMITHS MEDICAL PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT LEAKED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8355205 ↗
• MalfunctionDec 19, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX UNIPERC PERCUTANEOUS KIT TRACHEOSTOMY TUBE CUFF LEAKED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8181548 ↗